Clinical Impact of Cardiac Photon Counting CT

NCT05240807 | Completed FDA Device

• 2 other identifiers: 21-004933R01EB028590-02
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research trial is to determine whether images taken using a Photon Counting Detector CT scanner (PCD-CT) after the patient has received a drug that makes the heart work harder provide clinically important information about the severity of suspected coronary artery disease compared to CT imaging performed without using the drug that causes the heart to work harder.

Conditions

Coronary Artery Disease

Keywords

Coronary CT Angiography; Cardiac Stress Imaging; Photon Counting CT; Cardiac CT

Outcome Measures

Primary Outcomes (1)

• Change in disease status or post-exam recommendations

  A sub-specialty trained cardiac radiologist and a sub-specialty trained cardiologist will compare qualitative and quantitative results from the photon counting CT scans to the clinically ordered CT, MRI, or nuclear medicine scan. Clinically important differences in findings and recommendations will be recorded to assess the overall clinical impact of using photon-counting CT to assess patients with potential coronary artery disease, especially patients with heavily calcified, stented, or high-risk plaques, or having myocardial perfusion defects. Our premise is that the established benefits of PCD-CT, used with a dual-source geometry and advanced noise reduction and material decomposition algorithms, will yield clinically important differences in imaging findings that will impact patient management decisions.

  Through completion of CT exam, approximately 1 day

Study Arms (2)

Clinical Coronary CTA Cohort

EXPERIMENTAL

Subjects scheduled for a clinically indicated coronary CTA will receive a research contrast-enhanced coronary CT angiogram using photon-counting CT

Diagnostic Test: Photon counting computed tomography (PC-CT)

Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort

EXPERIMENTAL

Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test will receive a research contrast-enhanced coronary CT angiogram using photon-counting CT at rest and after administration of a cardiac stress agent

Diagnostic Test: Photon counting computed tomography (PC-CT)

Interventions

Photon counting computed tomography (PC-CT) DIAGNOSTIC_TEST

Cardiac CT imaging will be performed using a newly developed CT scanner that uses photon-counting detectors and the results compared to those from conventional CT, MRI, or nuclear medicine imaging systems

Clinical Coronary CTA Cohort; Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for coronary artery cardiac CT imaging or nuclear medicine or MRI cardiac perfusion within the Department of Radiology or Cardiology.
• Patients who are able and willing to sign the informed consent will be enrolled
• Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).

You may not qualify if:

• Patients unable to provide written informed consent
• Pregnancy
• eGFR ≤ 30
• History of prior moderate or severe contrast reaction includes: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
• Any history of required premedication prior to iodinated contrast administration.
• Patients that consent to participation but do not undergo their clinically-indicated, contrast-enhanced CT, or nuclear medicine or MR perfusion scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).
• Patients experiencing atrial fibrillation, premature ventricular contractions or other heart rhythm abnormalities
• Hospitalized patients or patients under care in the Emergency Department
• Anything by mouth within three hours of the examination
• Known hypersensitivity to Regadenoson, Adenosine, or Dipyridamole.
• Active ongoing wheezing or poorly controlled asthma or COPD (hospitalized within last month or receiving treatment for flair within last month).
• Second (type I or II) or third degree atrioventricular (AV) block or sinus node dysfunction unless patient has functioning artificial pacemaker.
• Ingested greater than 4 oz. of caffeine within the last 12 hours.
• Currently experiencing unstable coronary syndrome.
• Uncontrollable seizures within the last 3 months

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Boleyn Andrist

Eyota, Minnesota, 55934, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Cynthia McCollough, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 15, 2022
• Study Start: August 24, 2022
• Primary Completion: February 19, 2026
• Study Completion: March 19, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)